beyond pilot study

Conditions: Multiple Sclerosis; Relapsing-Remitting

Summary: the purpose of this study is to valuate safety and tolerability of betaseron.


Eligibility criteria:
inclusion criteria: diagnosis of rrms as defined by any of the following mcdonald diagnostic criteria (mcdonald et al 2001; see appendix 16.1.1 \[(protocol appendix 5\]): * two relapses and objective clinical evidence (history or present) of at least 2 lesions * two relapses and objective clinical evidence (history or present) of 1 lesion; and dissemination in space, demonstrated by mri (barkhof/tintoré criteria) or 2 mri t2 lesions consistent with ms plus positive csf. * one relapse with objective clinical evidence (history or present) of at least 2 lesions, and dissemination in time, demonstrated signs of disease activity ( new gd+ lesion or new t2 lesion) in an mri scan at least 3 months after the onset of that clinical event. * one relapse and objective clinical evidence (history or present) of 1 lesion, and dissemination in space, demonstrated by mri (barkhof/tintoré criteria); or 2 mri t2 lesions consistent with ms plus positive csf, and dissemination in time, demonstrated by signs of disease activity (new gd+ lesion or new t2 lesion) in an mri scan at least 3 months after the onset of that clinical event. * 18 to 55 years of age * score of 0-5.5 on the kurtzke expanded disability status scale' (edss; see appendix 16.1.1 \[protocol appendix 4\]) * naïve to immunomodulating therapies or previously treated with immunomodulating therapies other than any interferon (ifn) more than 30 days prior to the start of the study * if female of child-bearing potential, agreement to practice adequate contraception methods (iucd, condoms, oral contraceptives, or other adequate barrier contraception) * negative serum pregnancy test results. * signed and dated statement of informed consent exclusion criteria: * clinically significant heart disease such as uncontrolled cardiac dysrhythmia, angina pectoris, cardiomyopathy, or congestive heart failure * history of severe depression, suicide attempts, or current suicidal ideations * clinically significant liver, renal, and bone marrow dysfunction as defined by any of the following laboratory evaluations: * bone marrow dysfunction: * hb \<8.5 g/dl * wbc \<2.5 x 109/l * platelet count \<125 x 109/l * renal dysfunction: creatinine \>1.8 mg/dl * liver dysfunction: * asat (sgot) \>3xupper limit of normal * bilirubin \>2x upper limit of normal * epilepsy not adequately controlled by treatment * any conditions that could interfere with the mri or any other evaluation in the study * known allergy to human proteins including albumin and ifn, or to mannitol or gadolinium * participation in any clinical study within the past 30 days or use/intake of an investigational drug within the last 3 months prior to study entry * prior treatment with monoclonal antibody therapy, cladribine or total lymphoid irradiation * treatment with cytotoxic or immunosuppressive therapies (except systemic steroid or adrenocorticotropic hormone \[acth\]) within 6 months prior to study entry; or systemic steroid or acth within 1 month prior to study entry * presence of monoclonal gammopathy * inability to tolerate both nsaids and acetaminophen * pregnancy or lactation * history of alcohol or drug abuse * inability to administer subcutaneous injections either by self or by caregiver * medical, psychiatric or other conditions that compromise the patient's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study